EP1540343A4 - Verfahren zur beseitigung von störungen in immunochromatographischen assays - Google Patents

Verfahren zur beseitigung von störungen in immunochromatographischen assays

Info

Publication number
EP1540343A4
EP1540343A4 EP03765439A EP03765439A EP1540343A4 EP 1540343 A4 EP1540343 A4 EP 1540343A4 EP 03765439 A EP03765439 A EP 03765439A EP 03765439 A EP03765439 A EP 03765439A EP 1540343 A4 EP1540343 A4 EP 1540343A4
Authority
EP
European Patent Office
Prior art keywords
analyte
antibody
region
sample
binding pair
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP03765439A
Other languages
English (en)
French (fr)
Other versions
EP1540343B1 (de
EP1540343A1 (de
Inventor
Ronald G Sommer
Lloyd S Schulman
Daya C Wijesuriya
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=30443200&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1540343(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Publication of EP1540343A1 publication Critical patent/EP1540343A1/de
Publication of EP1540343A4 publication Critical patent/EP1540343A4/de
Application granted granted Critical
Publication of EP1540343B1 publication Critical patent/EP1540343B1/de
Anticipated expiration legal-status Critical
Revoked legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B38/00Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54306Solid-phase reaction mechanisms
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • G01N33/54388Immunochromatographic test strips based on lateral flow
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/97Test strip or test slide
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/807Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81Tube, bottle, or dipstick
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/825Pretreatment for removal of interfering factors from sample

Definitions

  • Anti-PSA goat IgG (2mg) was adjusted to a final volume of 1.25 mL with 50 mM borate (pH 8.5) in a test tube. This solution was added dropwise to the 1.25 mL of activated latex solution and stirred for 90 minutes at room temperature. 10 uL of 1M ethanolamine was added, followed by stirring for 30 minutes to quench the reaction and the addition of 100 uL of 5% (w/v) BSA with an additional 30 minutes of stirring to block any unbound binding sites.
  • the data of Table 2 demonstrate high reflectance in the capture band in the absence of PSA when an interfering serum is used as the sample.
  • the interference is eliminated by the addition of normal goat IgG, and, unlike the case in which the latex is conjugated with only goat anti-PSA (that is, biotin was absent), the reflectance in the collection band remained constant.
  • the interference is substantial in the absence of added goat IgG, providing a clearly false positive.
  • goat IgG is added, the interference is removed, but the collection band containing NeutrAvidin is effective, while in Table 1 the collection band gave no reading.
  • the non-interfering serum gave a small reading for PSA captured, but this result is considered to be a low level background signal.
  • Example 2 The procedure of Example 2 is repeated, except that the latex-labeled anti-PSA goat antibody and goat IgG are dried on the test strip in a form that can be resuspended before the first band containing immobilized anti-PSA monoclonal mouse antibody.
  • the strip When the strip is partially immersed in the serum sample, reaction between the PSA in the sample and the anti-PSA goat antibody occurs on the strip.
  • the sample migrates through the capture band where the bound anti-PSA goat antibody labeled with latex particles is also bound to the anti-PSA mouse antibody. Thereafter the sample migrates to the second collection band where the remaining unbound anti-PSA goat antibody labeled with latex particles is recovered by biotin on the latex binding to NeutrAvidin immobilized on the second band.

Landscapes

  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Ceramic Engineering (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Microbiology (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Steroid Compounds (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP03765439A 2002-07-19 2003-06-04 Verfahren zur beseitigung von störungen in immunochromatographischen assays Revoked EP1540343B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US198890 1980-10-20
US10/198,890 US7108993B2 (en) 2002-07-19 2002-07-19 Use of dual conjugated labels in the elimination of serum interference in immunochromatographic assays
PCT/US2003/017689 WO2004010142A1 (en) 2002-07-19 2003-06-04 Method for the elimination of interferences in immunochromatographic assays

Publications (3)

Publication Number Publication Date
EP1540343A1 EP1540343A1 (de) 2005-06-15
EP1540343A4 true EP1540343A4 (de) 2006-07-26
EP1540343B1 EP1540343B1 (de) 2008-08-20

Family

ID=30443200

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03765439A Revoked EP1540343B1 (de) 2002-07-19 2003-06-04 Verfahren zur beseitigung von störungen in immunochromatographischen assays

Country Status (8)

Country Link
US (1) US7108993B2 (de)
EP (1) EP1540343B1 (de)
AT (1) ATE405830T1 (de)
AU (1) AU2003248619A1 (de)
CA (1) CA2492090A1 (de)
DE (1) DE60323105D1 (de)
ES (1) ES2309353T3 (de)
WO (1) WO2004010142A1 (de)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070207496A1 (en) * 2004-11-19 2007-09-06 Larsen Oeistein Diagnostic control system
EP1957532A4 (de) * 2005-11-21 2009-11-11 Univ Oregon Health & Science Verfahren und reagentien zur eliminierung oder reduktion von falsch positiven resultaten bei der analyse einer probe
NL1033365C2 (nl) 2007-02-09 2008-08-12 Medavinci Dev B V Inrichting en werkwijze voor scheiden en analyseren van bloed.
NL2001577C2 (nl) * 2008-05-14 2009-11-17 Medavinci Dev B V Inrichting en werkwijze voor scheiden en analyseren van bloed.
US8084272B2 (en) * 2009-03-25 2011-12-27 Abbott Point Of Care Inc. Amelioration of heterophile antibody immunosensor interference
US20100317033A1 (en) * 2009-06-10 2010-12-16 Matthew Philip Abdel Methods and materials for detecting food containing allergens
KR101291245B1 (ko) * 2009-11-27 2013-07-30 한국전자통신연구원 미세유체제어 칩 및 미세유체제어 칩에서의 단백질 검출 방법
SG11201608278WA (en) 2014-04-02 2016-10-28 Chembio Diagnostic Systems Inc Immunoassay utilizing trapping conjugate
CN104020289B (zh) * 2014-06-23 2015-09-30 宁波艾科生物科技有限公司 一种筛选抗原不同结合位点的单克隆抗体的方法
CN112129955B (zh) * 2019-06-25 2023-04-07 迈克生物股份有限公司 睾酮检测试剂盒

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1046913A2 (de) * 1999-04-22 2000-10-25 Bayer Corporation Immunochromatographisches Assay
US6146836A (en) * 1997-05-19 2000-11-14 Bayer Corporation Immunoassays using anti-allotypic monoclonal antibodies
EP1197754A1 (de) * 2000-10-13 2002-04-17 Tang J. Wang Methoden und Vorrichtung zur Detektion von PSA

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EP1046913A2 (de) * 1999-04-22 2000-10-25 Bayer Corporation Immunochromatographisches Assay
EP1197754A1 (de) * 2000-10-13 2002-04-17 Tang J. Wang Methoden und Vorrichtung zur Detektion von PSA

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Also Published As

Publication number Publication date
EP1540343B1 (de) 2008-08-20
EP1540343A1 (de) 2005-06-15
ATE405830T1 (de) 2008-09-15
AU2003248619A1 (en) 2004-02-09
ES2309353T3 (es) 2008-12-16
DE60323105D1 (de) 2008-10-02
WO2004010142A1 (en) 2004-01-29
CA2492090A1 (en) 2004-01-29
US20040014157A1 (en) 2004-01-22
US7108993B2 (en) 2006-09-19

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